Follow-up-study of COPD Patients and Healthy Controls for Evaluation of Predictive Non-coding RNA Biomarkers

NCT02522026 | Completed

• 1 other identifier: 15-01 RIBO II
• Study Type: observational
• Target: 116
• Locations: 1 country
• Sites: 1

Brief Summary

Between 2012 and 2014, a cohort of 90 COPD subjects of disease severity grades GOLD I-IV as well as 60 healthy control subjects (30 smokers and 30 non-smokers) have been examined regarding different clinical and blood/ sputum derived biomarkers at the investigators' research center. This observation study will follow-up/re-examine all available subjects regarding disease course and treatment changes after 3 years (+/-6 months) for the investigation of ncRNA/ transcriptome biomarkers for their potential to indicate disease progression. In addition, biobanking of respective biosamples for potential future COPD biomarker research will be conducted.

Conditions

Chronic Obstructive Pulmonary Disease

Outcome Measures

Primary Outcomes (1)

• Lung volumes by pulmonary function testing

  forced expiratory volume in 1 second

  after 3 years ± 6 months

Study Arms (5)

Healthy volunteers

Healthy smokers

COPD GOLD1

COPD GOLD2

COPD GOLD3/4

Eligibility Criteria

• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

All 150 patients of study "11-03 Ribolution" will be contacted and re-invited for the current follow-up study as completely as possible

You may qualify if:

• Participants in Study "11-03 Ribolution"
• Able and willing to give written informed consent
• Not pregnant, as confirmed by pregnancy test

You may not qualify if:

• Past or present disease occurred since participation in "11-03 Ribolution", which as judged by the investigator, may affect the outcome of the study.
• Serious, uncontrolled disease (including serious psychological disorders) likely to interfere with the study or impact on subject safety
• Has experienced a significant upper or lower respiratory tract infection incl. moderate or severe exacerbation (requiring oral corticosteroid, antibiotics or hospitalisation) within the last 4 weeks. All courses of oral corticosteroids and antibiotics must be completed at least 4 weeks before study start
• Clinically significant pathological findings in safety laboratory tests having an impact on study participation.
• Actual drug or alcohol abuse.
• Suspected inability to understand and follow protocol requirements, instructions, study-related restrictions, and to understand nature, scope, and possible consequences of the study.
• Being a vulnerable subject (dependent, in detention, or without mental capacity)

Sponsors & Collaborators

• Fraunhofer-Institute of Toxicology and Experimental Medicine: lead

Study Sites (1)

Fraunhofer-Institute for Toxicology and Experimental Medicine

Hanover, 30625, Germany

Location

Biospecimen

Retention: SAMPLES WITH DNA

blood, sputum

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Study Officials

• Jens M Hohlfeld, Prof

  Fraunhofer Institute for Toxicology and Experimental Medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Division Director Airway Research

Study Record Dates

• First Submitted: August 7, 2015
• First Posted: August 13, 2015
• Study Start: August 1, 2015
• Primary Completion: March 1, 2017
• Study Completion: March 1, 2017
• Last Updated: February 25, 2025

Record last verified: 2025-02

Locations

DE (1)